Label: OMEPRAZOLE tablet, delayed release
- NDC Code(s): 57483-840-01, 57483-840-42
- Packager: INNOVUS PHARMACEUTICALS, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 10, 2020
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- Official Label (Printer Friendly)
- Active ingredient(in each tablet)
- Purpose
- Keep Out of Reach of Children
- Use
- Warnings
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Directions
- •
- for adults 18 years of age and older
■ this product is to be used once a day (every 24 hours), every day for 14 days
■ it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours
14-Day Course of Treatment
■ swallow 1 tablet with a glass of water before eating in the morning
■ take every day for 14 days
■ do not take more than 1 tablet a day
■ do not use for more than 14 days unless directed by your doctor
■ swallow whole. Do not chew or crush tablets.
Repeated 14-Day Courses (if needed)
■ you may repeat a 14-day course every 4 months
■ do not take for more than 14 days or more often than every 4 months unless directed by a doctor
■ children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition
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Inactive ingredients
anhydrous lactose, hypromellose, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose monohydrate, methyl cellulose, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, triethyl citrate and titanium dioxide. The imprinting ink contains ammonium hydroxide, black iron oxide, n-butyl alcohol, propylene glycol and shellac.
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
OMEPRAZOLE
omeprazole tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57483-840 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) (UNII: 36BGF0E889) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MONOETHANOLAMINE (UNII: 5KV86114PT) METHYLCELLULOSE (1500 MPA.S) (UNII: P0NTE48364) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) AMMONIA (UNII: 5138Q19F1X) FERROSOFERRIC OXIDE (UNII: XM0M87F357) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) SHELLAC (UNII: 46N107B71O) Product Characteristics Color BROWN (brownish pink) Score no score Shape OVAL (biconvex) Size 12mm Flavor Imprint Code 20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57483-840-42 3 in 1 CARTON 08/10/2020 1 NDC:57483-840-01 14 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207891 08/10/2020 Labeler - INNOVUS PHARMACEUTICALS, INC. (962507187) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 650445203 MANUFACTURE(57483-840)
